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Table 1 Inclusion and exclusion criteria of the study

From: Landiolol, an ultra-short acting beta-1 blocker, for preventing postoperative lung cancer recurrence: study protocol for a phase III, multicenter randomized trial with two parallel groups of patients

Inclusion criteria

Patients may enter the trial if all of the following apply:

1. Non-small-cell lung cancer is suspected

2. Radiologically diagnosed invasive lung tumor (a consolidation diameter > 5 mm or a whole lesion diameter > 30 mm is visualized by thin-section computed tomography)

3. Complete lobectomy planned

4. Complete resection including mediastinal lymph node dissection is planned

5. No synchronous or metachronous (within five years) malignancies, except for carcinoma in situ or mucosal tumors curatively treated with local therapy

6. Age ≥ 20 years

7. Eastern Cooperative Oncology Group performance status 0–1

8. Sufficient organ function (leukocyte count ≥ 1500/mL, platelet count ≥ 100,000/mL, hemoglobin ≥ 8.0 g/dL, total bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase ≤ 100 IU/L, alanine aminotransferase ≤ 100 IU/L, peripheral arterial oxygen saturation on room air ≥ 92%)

9. Written informed consent from the patient

Exclusion criteria

Patients may not enter the trial if any of the following apply:

1. Active concurrent malignant diseases

2. Mental disorders that may affect the ability or willingness to provide informed consent or abide by the study protocol

3. Beta blocker medication necessary

4. Beta-2 stimulator medication necessary

5. Preoperative chemotherapy and/or radiotherapy to the target lesion

6. Systemic steroids or immunosuppressive agent medication

7. Uncontrollable infectious disease except for viral hepatitis

8. Serious complications (congestive heart failure, serious coronary insufficiency, acute myocardial infarction, renal failure, liver failure, hemorrhagic gastric ulcer, intestinal paralysis, intestinal obstruction, uncontrollable diabetes mellitus, etc.)

9. Uncontrollable autoimmune disease

10. Contraindicated for the test drug

- cardiogenic shock

- diabetic ketoacidosis or metabolic acidosis

- bradycardia including atrioventricular block and sick sinus syndrome

- right cardiac failure due to pulmonary hypertension

- untreated pheochromocytoma

- history of hypersensitivity to the test drug

11. Pregnant, lactating, or potentially pregnant

12. Participating in another clinical trial at time of enrolment

13. Deemed unsuitable by the primary investigator for other reasons